Associate Director, Digital QA

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

• Acting as the primary backup when the Digital QA Team Lead is unavailable:
  • Oversee daily operations of the Digital QA team to ensure timely and effective task execution.
  • Act as the main point of contact between the Digital QA team and the Head of QA.
  • Manage intake, prioritization, and assignment of tasks within the Digital QA portfolio.
  • Report on Digital QA performance and key activities for stakeholders.
  • Escalate quality issues and ensure proactive stakeholder communication and alignment.

• Chair the Process Expert Group on Computerized Systems to support governance and compliance.
• Review and approve relevant SOPs, Work Instructions (WIs), and QMS policies.

• Maintain subject matter expertise in GxP regulations and best practices for CSV/CSA.
• Ensure Genmab's validation strategies align with current regulatory expectations and industry standards.
• Drive continuous improvement in validation processes and advocate for a risk-based approach.
• Provide quality oversight for lifecycle activities of IT GxP systems, including implementation, operation, and decommissioning.
• Review and approve validation documentation, including System Periodic Reviews.
• Support project managers and validation leads in aligning with Genmab's CSV/CSA procedures.

• Plan, lead, and report internal IT audits; participate in external audits as Digital QA SME.
• Ensure readiness for regulatory inspections related to IT systems and infrastructure.
• Oversee audit follow-up, including CAPA development and implementation.
• Support vendor onboarding, qualification, and audits of GxP-relevant vendors and CROs/CMOs.
• Train and guide IT personnel on GxP compliance and Good Documentation Practices.

• Bachelor's or Master's degree in Life Sciences, Computer Science, or a related field.
• 8+ years of experience in Quality Assurance within the pharmaceutical or biotech industry, preferably with a focus on IT or digital systems.
• Strong understanding of GxP regulations (e.g., FDA, EMA), CSV, CSA, and data integrity principles.
• Experience participating in inspections and audits in a regulated environment.
• Proven stakeholder management and leadership skills.
• Excellent communication, documentation, and problem-solving abilities.

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so!